SUMMARY

• Janssen does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
• MajesTEC-2 (MMY1004) is an ongoing, phase 1b, multicohort study evaluating TECVAYLI in combination with other anticancer therapies in patients with multiple myeloma (MM). Cohort D is evaluating the efficacy and safety of TECVAYLI in combination with lenalidomide in patients with triple-class exposed MM who received ≥2 prior lines of therapy (LOTs).^1,2
  • Tan et al (2023)² presented the efficacy and safety of TECVAYLI in combination with lenalidomide in 31 patients at a median follow-up of 10.8 months (range, 1.1-16.8). The overall response rate (ORR) was 74.2%. The most common adverse events (AEs; any grade) were infections (80.6%), neutropenia (74.2%), and cytokine release syndrome (CRS; 67.7%).

CLINICAL DATA - majestec-2 study - cohort d

MajesTEC-2 (MMY1004; clinicaltrials.gov identifier: NCT04722146) is an ongoing, phase 1b, multicohort study evaluating the efficacy and safety of TECVAYLI in combination with other anticancer treatments in patients with MM.^1,2

• Cohort D is evaluating the efficacy and safety of TECVAYLI in combination with lenalidomide in 31 patients with triple-class exposed MM who received ≥2 prior LOTs.²

Study Design/Methods

• The study design is presented in Figure: MajesTEC-2 (Cohort D): Study Design.^1,2

Tan et al (2023)² presented the efficacy and safety of TECVAYLI in combination with lenalidomide at a median follow-up of 10.8 months (range, 1.1-16.8).

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

• Patient and disease characteristics are presented in Table: MajesTEC-2 Study (Cohort D): Baseline Demographics and Disease Characteristics.

Efficacy

• All patients were evaluable for response. The ORR was 74.2%, complete response or better (≥CR) was 35.5%, and very good partial response or better (≥VGPR) was 64.5%.
• The median follow-up among responders was 11.4 months (range, 3.9-16.8). The median time to first response was 1.2 months (range, 0.8-4.4) and the median time to best response was 3.7 months (range, 1.0-13.1). At data cutoff, the median duration of response (DOR) was not reached.

Safety

• AEs reported in ≥25% of patients at both dose levels are presented in Table: MajesTEC-2 Study (Cohort D): AEs (≥25% Overall).
• Two patients (6.5%) reported grade 3/4 febrile neutropenia.
• Treatment discontinuations due to AEs were reported in 5 patients (16.1%).
• Three AE-related deaths (9.7%) were reported (sepsis [n=1], coronavirus disease [COVID-19; n=1], and acute renal failure associated with progressive disease [n=1]).

Cytokine Release Syndrome

• CRS of any grade was reported in 67.7% of patients (n=21). One patient reported a grade 3 CRS event (with associated grade 3 hypotension) that occurred during TECVAYLI step-up dose 2.
• The median time to onset of CRS was 2.0 days (range, 1-4), with a median duration of 2.0 days (range, 1-15).
• One patient had a subsequent CRS event during cycle 2. All other CRS events occurred during TECVAYLI step-up dosing or cycle 1.

Neurotoxicity

• Immune effector cell-associated neurotoxicity syndrome (ICANS) events (both grade 1) were reported in 2 patients (6.5%).

Infections

• Infections of any grade were reported in 80.6% of patients (n=25), with grade 3/4 infections reported in 45.2% of patients (n=14). The most frequently reported infections were pneumonia (22.6%, all grade 3/4), COVID-19 (any grade: 19.4%; grade 3/4: 3.2%), and sepsis (any grade: 16.1%; grade 3/4: 9.7%).

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 21 March 2025.